Home Medizin Analysepreise für neue US-Arzneimittel stiegen im Jahr 2023 um 35 %, mehr als im Vorjahr

Analysepreise für neue US-Arzneimittel stiegen im Jahr 2023 um 35 %, mehr als im Vorjahr

von NFI Redaktion

(Reuters) – According to a Reuters analysis, pharmaceutical companies introduced new US medicines last year at prices 35% higher than in 2022, partly due to the industry accepting expensive therapies for rare diseases such as muscular dystrophy.

The analysis of 47 drugs by Reuters found that the average annual list price for a new medicine in 2023 was $300,000, up from $222,000 the previous year. According to a study published in JAMA, the average annual price for the 30 drugs first marketed by mid-July in 2021 was $180,000.

More than half of the new products approved by the Food and Drug Administration in 2023 and 2022 were intended for rare diseases, affecting less than 200,000 Americans, and some of them are not expected to be major sellers. The orphan drug designation rate is slightly above the 49% of the last five years.

A high price may be justified for a drug with significant benefits for patients, but „prices continue to rise without a clear rationale,“ said Dan Ollendorf, Chief Science Officer at the Institute for Clinical and Economic Review (ICER), an influential group that evaluates the value and prices of drugs.

He said that prices for many drugs for rare diseases and cancer do not align with their benefits, but the lack of alternatives gives manufacturers leverage in negotiations.

Reuters analyzed 55 novel drugs approved by the FDA last year, compared to 37 in 2022. The agency’s biologics division approved 17 new products, including four gene therapies.

The analysis excludes vaccines and drugs used temporarily, such as Pfizer’s antiviral COVID-19 drug Paxlovid. Also excluded are drugs not yet commercially available.

Of the 47 drugs included in the analysis, the highest price for regularly taken medications was $1.8 million per year for Regeneron’s Veopoz against CHAPLE disease, a rare condition affecting fewer than 100 people worldwide where parts of the immune system become overactive.

The lowest annual price was $576 for the diabetes drug Brenzavvy, sold by TheracosBio in collaboration with Mark Cuban’s online pharmacy Cost Plus Drugs.

Ollendorf from ICER said it is too early to say if TheracosBio’s strategy of „disrupting“ the typical drug contracting model by selling a drug in a widely used class at a much lower price than competitors will be successful.

Brian Connelly, CEO of TheracosBio, said that „sales of Brenzavvy are rapidly increasing,“ but did not provide details.

MARKET INCENTIVES

Gene therapies, which are one-time treatments, range in price from $2.2 million for Vertex and CRISPR’s Casgevy for sickle cell anemia to $3.2 million for Sarepta’s Elevydis for muscular dystrophy.

The US provides drug manufacturers with market exclusivity, fee waivers, direct funding for research and development, and tax credits for such rare treatments.

„We have created many incentives for innovation in rare diseases and the market has responded,“ said Dana Goldman, Director of the USC Schaeffer Center for Health Policy & Economics. „The hope is that we will eventually see therapeutic competition in this area and prices will decrease.“

The Inflation Reduction Act of 2022 limits how much drug manufacturers can increase prices for treatments offered under Medicare, the federal health plan for individuals over 65. The legislation does not restrict the amount of fees for new drugs.

„This means that you are encouraging companies to come to market at high prices,“ said Goldman.

Drug manufacturers emphasize that they do not determine what US patients ultimately pay. Many offer savings cards and other programs to reduce out-of-pocket costs, while health insurers can receive discounts and rebates on manufacturers‘ list prices, especially when competing treatments are available.

Drug manufacturers also say that new drugs offer cost savings, including the potential for fewer emergency room visits and hospital stays.

The Boston Consulting Group predicts that 24% of new drugs in 2023 will achieve blockbuster status – annual revenue exceeding $1 billion – down from 35% in 2022.

As patents expire, cheaper generics mitigate the price increase in prescription drugs, which in the twelve months to December, according to the US government, equated to a general inflation of 3.3%.

(Reporting by Bill Berkrot)

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